Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clotrimazole
The Boots Company Plc
D01AC01
Clotrimazole
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100200; GTIN: 5000167082425
QUERIES FOR CLIENTS ANY ‘CLIENT QUERY’ BOXES WILL BE VISIBLE IN RED AND WILL BE AUTOMATICALLY REMOVED ON APPROVAL OF THE ARTWORK. APPROVAL BY THE ADMIN ‘MASTER’ APPROVER WILL SIGNIFY THAT YOU ARE HAPPY TO PROCEED TO PRINT WITHOUT ACTION BEING TAKEN WITH REGARDS TO THE CLIENT QUERY. UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM WK360. TECHNICAL INFORMATION, PRINTER PLEASE NOTE: WK360 HAVE CREATED THIS ARTWORK TO A GENERIC PRINT PROCESS SPECIFICATION AND REPRO HAS NOT BEEN APPLIED. PLEASE CALL YOUR CLIENT CONTACT TO DISCUSS ANY AMENDS OR IF ANYTHING FALLS BENEATH YOUR PRINT TOLERANCES Applescan House, Latimer Road, Luton, Beds, LU1 3XE TEL: 01582 487580 / 01582 456082 WEB: wk360.com BRANDING 27/05/2021 DMC - Martyn Price PRINTING COLOURS PMS 285 C PMS 280 C Cutter Guides BRAILLE TECHNICAL & NON-PRINTING SPECIAL FINISHES & FOILS 5299 THIS SCALE MEASURES 50MM WHEN ARTWORK IS AT 100% 0 10 20 30 40 50 CATEGORY: SYNERGIST JOB NO: BRAND: RANGE: ITEM CODE: BARCODE TYPE: BARCODE NO.: PROJECT NO.: PRODUCT TITLE: FILE NAME: PROOF NUMBER: PROOF DATE: ARTWORKER: PACK TYPE: SUPPLIER CONTACT: FINISH: FINISH TYPE: SUBSTRATE: SUBSTRATE COLOUR: SUPPLIER DETAILS: PRINTER CONTACT: PRINTER DETAILS: NUMBER OF COLOURS: BRAILLE: Health Boots Own Brand Womens Health 6104924 EAN13 5000167082425 6 Gloss Pattern Carton Board White 2 Yes Teva Helen.Sole@tevauk.com WBA-1253-Antifungal Cream 20g Carton-6104924 PACK MOCK UP ARTWORK TEXT SIZE MAIN HEADINGS: 8pt SUB HEADINGS: 7pt BODY HEADINGS: 6.5pt PACK DIMENSIONS HEIGHT: 113mm WIDTH: 37mm DEPTH: 30mm VERSION NO. DATE ISSUED REASON FOR CHANGE 1 03/03/2021 Excipient warning update 00289/1490 MHRA approved v1 13/01/2020 WBAG384905 B Internally approved 20 g Aluminium tube with polypropylene screw on cap containing 20 g of cream. Antifungal Cream PRODUCT NAME: PRODUCT LICENCE NO.: WORDING REF: STATUS: PACK DETAILS: PACK SIZE: Artwork Only GLOSS VARNISH READ ALL OF THIS CARTON FOR FULL INSTRUCTIONS. WHAT THIS MEDICINE IS FOR An antifungal cream for the t Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lloydspharmacy Antifungal Skin Cream Clotrimazole 1% w/w Cream Boots Antifungal Cream Tesco Antifungal Cream Careway Antifungal 1% w/w Skin Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 1% w/w 3 PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of skin infections due to dermatophytes (e.g. trycophyton species), yeasts (e.g. candida species), moulds and other fungi. These include ringworm (tinea) infections, paronychia, pityriasis versicolor, erythrasma and intertrigo, as well as fungal nappy rash, candidal vulvitis and candidal balanitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage: Adult, children and elderly: Apply to the affected area two or three times daily Dermatophyte infections: treat for at least one month Candida infections: treat for at least two weeks Route of administration: Directly applied to the affected area. A physician should be consulted if symptoms do not improve within 7 days. 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the components 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reaction (e.g. contact dermatitis). Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Clotrimazole Cream may cause damage to latex contraceptives. Consequentially patients should be advised to use alternative precautions for at least five days after using this product. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy Data on a large number of exposed pregnancies indicate no adverse effects of Clotrimazole on pregnancy or on the health of the foetus/newborn child. To date, no othe Leggi il documento completo